Safety valve assembly for implantable benefical agent infusion device

• US 6,488,652 B1
• Filed: 01/31/2000
• Issued: 12/03/2002
• Est. Priority Date: 02/02/1998
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Weijand, Koen J., Haller, Markus
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): SIRMONS, KEVIN C
• Application Number:
  US09/494,530
• Time in Patent Office: 1,037 Days
• Field of Search: 604/890.1, 604/891.1, 604/892.1, 604/131, 604/132, 604/151, 604/153, 604/154, 604/246, 604/247, 604/256, 604/93.01, 604/65-67, 604/236, 604/237, 604/238
• US Class Current: 604/93.01
• CPC Class Codes: A61M 2205/0294 Piezoelectric materials
• CPC Class Codes: A61M 39/22 Valves or arrangement of valves A61M39/02, A61M39/0247, A61M39/16 take precedence; regulating valves in infusion systems A61M5/16881; in devices worn by the patient for the reception of urine, faeces, catamenial or other discharge, or in colostomy devices A61F5/4405
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/1428 with manual pumping action
• CPC Class Codes: A61M 5/16831 Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066

Abstract

An implantable beneficial agent infusion device featuring a unique safety valve assembly is disclosed. In one embodiment of the present invention, a seal in the safety valve assembly is normally closed and only opens upon a deflectable or moveable member to which the seal is attached being electrically, magnetically or electromagnetically activated. The valve assembly is preferably small in size and made of corrosion resistant materials. The valve assembly may be employed in either a passive or an active implantable drug or beneficial agent infusion system.

Claims

1. An implantable beneficial agent infusion device, comprising:

an hermetically sealed enclosure;

a fluid reservoir positioned at least partially within the hermetic enclosure, the fluid reservoir having means for maintaining a fluid containing a beneficial agent disposed therewithin between a first pressure and a second pressure;

means for delivering the fluid into a patient'"'"'s body;

a controllable pump, the pump communicating with the reservoir and the means for delivering the fluid into a patient'"'"'s body and causing the fluid to move from the reservoir into the means for delivering a fluid into a patient'"'"'s body upon receiving a command actuating same; and

a safety valve assembly comprising a first substrate, a deflectable, moveable upper member having upper and lower surfaces, a compressible seal having upper and lower surfaces, a deflectable, moveable lower member having upper and lower surfaces, and means for controllably energizing and deflecting the lower member by providing an output signal thereto;

wherein the upper surface of the upper member forms a portion of the fluid reservoir and is in contact with the fluid, the fluid exerting a pressure on the upper surface of the upper member, the lower surface of the upper member engaging the top surface of the seal, the lower surface of the seal being affixed to the lower member and seatable against the first substrate, the upper surface of the seal being seatable against the lower surface of the upper member, the lower surface of the upper member being mechanically biased against the upper surface of the seal when the seal is in a closed position, the energizing and deflecting means being electrically coupled to the upper and lower surfaces of the lower member, the lower member being deflectable or moveable between a first non-energized position in which movement of the fluid from the reservoir into the means for delivering the fluid into the patient'"'"'s body is blocked and the seal is in a closed position, and a second energized position in which the movement of the fluid from the reservoir into the means for delivering the fluid into the patient'"'"'s body is permitted as the seal is further pushed against the lower surface of the upper member into an open position through deflection or movement of the lower member occurring in response to the output signal being provided to the lower member, the fluid moving into the means for delivering the fluid into the patient'"'"'s body and the upper member being deflected further inwardly into the fluid reservoir when the seal is pushed into the open position.

2. The implantable medical device of claim 1, wherein the seal is attached to the lower member by an intermediate member disposed therebetween.

3. The implantable medical device of claim 1, wherein a connecting member is disposed between the seal and the lower member, the connecting member being attached to the upper surface of the lower member.

4. The implantable medical device of claim 1, wherein the upper member is a membrane.

5. The implantable medical device of claim 1, wherein the upper member is formed of a material selected from the group consisting of metal, titanium, and silicone.

6. The implantable medical device of claim 1, wherein the upper member has thickness selected from the group consisting of ranging between about 25 microns and about 100 microns and ranging between about 10 microns and about 20 microns.

7. The implantable medical device of claim 1, wherein the seal comprises a material selected from the group consisting of silicone rubber, PTFE, polyimide and a polymeric substance.

8. The implantable medical device of claim 1, wherein the seal has a diameter ranging between about 1 mm and about 3 mm, or ranging between about 25 microns and about 50 microns.

9. The implantable medical device of claim 1, wherein the seal is attached to the lower member by an intermediate member disposed therebetween, the intermediate member comprising a nipple and an end cap, the end cap being disposed closest to the bottom surface of the seal and the nipple being disposed closest to the lower member.

10. The implantable medical device of claim 9, wherein the nipple comprises a first material selected from the group consisting of glass, silicon, silicone rubber, titanium, and metal and wherein the end cap comprises a second material selected form the group consisting of glass, silicon, silicone rubber, titanium and metal.

11. The implantable medical device of claim 1, wherein the intermediate member has a second diameter which is approximately one-half that of a first diameter of the seal.

12. The implantable medical device of claim 1, wherein the intermediate member has a diameter ranging between about 0.5 mm and about 1.5 mm.

13. The implantable medical device of claim 1, wherein the fluid exerts a pressure against the upper surface of the upper member when the seal is in the open position.

14. The implantable medical device of claim 1, wherein the fluid exerts a pressure against the upper surface of the upper member when the seal is in the closed position.

15. The implantable medical device of claim 1, wherein the upper member further comprises ends, the ends being attached to shoulders.

16. The implantable medical device of claim 1, wherein connecting means attaching the ends of the upper member to the shoulders are selected from the group consisting of brazing, welding, anodic bonding, and silicon fusion bonding.

17. The implantable medical device of claim 1, wherein the lower member comprises a piezo-electric material.

18. The implantable medical device of claim 1, wherein the seal is attached to the lower member by an intermediate member disposed therebetween, a connecting member further being disposed between the intermediate member and the lower member, the connecting member being attached to the upper surface of the lower member.

19. The implantable medical device of claim 1, wherein a connecting member is disposed between the intermediate member and the lower member, the connecting member being attached to the upper surface of the lower member and comprising an adhesive.

20. The implantable medical device of claim 19, wherein the adhesive comprises electrically conductive epoxy.

21. The implantable medical device of claim 1, wherein the lower member comprises an electro-capacitive material.

22. The implantable medical device of claim 1, wherein the lower member comprises an electro-static material.

23. The implantable medical device of claim 1, wherein the lower member comprises a solenoid.

24. The implantable medical device of claim 1, wherein the seal can move into the open position only so long as the pressure of the fluid applied to the upper surface of the upper member does not exceed a predetermined limit.

25. The implantable medical device of claim 1, wherein an integrated circuit comprising a driving circuit receives electrical current from a battery and transforms the current into an output signal appropriate to cause the lower member to move upwardly in response to the application of an electrical field thereto such that the sealing means moves into the open position.

26. The implantable medical device of claim 25, wherein once the output signal applied across the lower member is withdrawn, the seal returns to the closed position.

27. The implantable medical device of claim 1, wherein the safety valve assembly further comprises surfaces which come into contact with the fluid, the surfaces having a coating of diamond or diamond-like carbon disposed thereon to minimize interactions between the fluid and the materials comprising such surfaces.

37. The implantable medical device of claim 27, wherein the nipple comprises a first material selected from the group consisting of glass, silicon, silicone rubber, titanium, and metal and wherein the end cap comprises a second material selected form the group consisting of glass, silicon, silicone rubber, titanium and metal.

28. An implantable means for infusing a fluid beneficial agent into a patient'"'"'s body, comprising:

an hermetically sealed means for enclosing;

a means for containing the fluid positioned at least partially within the enclosing means, the fluid containing means having means for maintaining the fluid disposed therewithin between a first pressure and a second pressure;

means for delivering the fluid into the patient'"'"'s body;

controllable means for pumping, the pumping means communicating with the fluid containing means and the means for delivering the fluid into a patient'"'"'s body and causing the fluid to move from the fluid containing means into the means for delivering a fluid into the patient'"'"'s body upon receiving a command actuating the pumping means; and

a safety valve assembly comprising a first substrate, a first upper means for moving having upper and lower surfaces, a means for sealing having upper and lower surfaces, a second lower means for moving having upper and lower surfaces, and means for controllably energizing and deflecting the lower member by providing an output signal thereto or thereacross;

wherein the upper surface of the upper moving means forms a portion of the fluid containing means and is in contact with the fluid, the fluid exerting a pressure on the upper surface of the upper moving means, the lower surface of the upper moving means engaging the top surface of the sealing means, the lower surface of the sealing means being affixed to the lower moving means and seatable against the first substrate, the upper surface of the sealing means being seatable against the lower surface of the upper moving means, the lower surface of the upper moving means being mechanically biased against the upper surface of the sealing means when the sealing means is in a closed position, the energizing and deflecting means being electrically coupled to the upper and lower surfaces of the lower moving means, the lower moving means being deflectable or moveable between a first non-energized position in which movement of the fluid from the reservoir into the means for delivering the fluid into the patient'"'"'s body is blocked when the sealing means is in a closed position, and a second energized position in which the movement of the fluid from the reservoir into the means for delivering the fluid into the patient'"'"'s body is permitted as the sealing means is further pushed against the lower surface of the upper moving means into an open position through deflection or movement of the lower moving means occurring in response to the output signal being provided to the lower moving means, the fluid moving into the means for delivering the fluid into the patient'"'"'s body and the upper moving means being deflected further inwardly into the fluid containing means when the sealing means is pushed into the open position.

29. The implantable medical device of claim 28, wherein the sealing means is attached to the lower moving means by an intermediate member disposed therebetween.

30. The implantable medical device of claim 28, wherein a connecting member is disposed between the sealing means and the lower moving means, the connecting member being attached to the upper surface of the lower moving means.

31. The implantable medical device of claim 28, wherein the upper moving means is a membrane.

32. The implantable medical device of claim 28, wherein the upper moving means is formed of a material selected from the group consisting of metal, titanium, and silicone.

33. The implantable medical device of claim 28, wherein the upper moving means has thickness selected from the group consisting of ranging between about 25 microns and about 100 microns and ranging between about 10 microns and about 20 microns.

34. The implantable medical device of claim 28, wherein the sealing means comprises a material selected from the group consisting of silicone rubber, PTFE, polyimide and a polymeric substance.

35. The implantable medical device of claim 28, wherein the sealing means has a diameter ranging between about 1 mm and about 3 mm, or ranging between about 25 microns and about 50 microns.

36. The implantable medical device of claim 28, wherein the sealing means is attached to the lower moving means by an intermediate member disposed therebetween, the intermediate member comprising a nipple and an end cap, the end cap being disposed closest to the bottom surface of the sealing means and the nipple being disposed closest to the lower moving means.

38. The implantable medical device of claim 28, wherein the intermediate member has a second diameter which is approximately one-half that of a first diameter of the sealing means.

39. The implantable medical device of claim 28, wherein the intermediate member has a diameter ranging between about 0.5 mm and about 1.5 mm.

40. The implantable medical device of claim 28, wherein the fluid exerts a pressure against the upper surface of the upper moving means when the sealing means is in the open position.

41. The implantable medical device of claim 28, wherein the fluid exerts a pressure against the upper surface of the upper member when the sealing means is in the closed position.

42. The implantable medical device of claim 28, wherein the upper moving means further comprises ends, the ends being attached to shoulders.

43. The implantable medical device of claim 28, wherein connecting means attaching the ends of the upper moving means to the shoulders are selected from the group consisting of brazing, welding, anodic bonding, and silicon fusion bonding.

44. The implantable medical device of claim 28, wherein the lower moving means comprises a piezo-electric material.

45. The implantable medical device of claim 28, wherein the sealing means is attached to the lower moving means by an intermediate member disposed therebetween, a connecting member further being disposed between the intermediate member and the lower member, the connecting member being attached to the upper surface of the lower moving means.

46. The implantable medical device of claim 28, wherein a connecting member is disposed between the intermediate member and the lower moving, the connecting member being attached to the upper surface of the lower moving means and comprising an adhesive.

47. The implantable medical device of claim 46, wherein the adhesive comprises electrically conductive epoxy.

48. The implantable medical device of claim 28, wherein the lower moving means comprises an electro-capacitive material.

49. The implantable medical device of claim 28, wherein the lower moving means comprises an electro-static material.

50. The implantable medical device of claim 28, wherein the lower moving means comprises a solenoid.

51. The implantable medical device of claim 28, wherein the sealing means can move into the open position only so long as the pressure of the fluid applied to the upper surface of the upper moving means does not exceed a predetermined limit.

52. The implantable medical device of claim 28, further comprising means for providing an output signal to the lower moving means, the output signal being suitable to cause the lower moving means to move upwardly in response to the application of an electrical field thereto such that the sealing means moves into the open position.

53. The implantable medical device of claim 52, wherein once the output signal applied across the lower moving means is withdrawn, the sealing means returns to the closed position.

54. The implantable medical device of claim 28, wherein the safety valve assembly further comprises surfaces, the surfaces coming into contact with the fluid having a coating of diamond or diamond-like carbon disposed thereon to minimize interactions between the fluid and the materials comprising such surfaces.

55. A method of making an implantable beneficial agent infusion device, the device comprising an hermetic enclosure, a fluid reservoir positioned at least partially within the hermetic enclosure, the fluid reservoir having means for maintaining a fluid containing a beneficial agent disposed therewithin between a first pressure and a second pressure, means for delivering the fluid into a patient'"'"'s body, a controllable pump, the pump communicating with the reservoir and the means for delivering the fluid into a patient'"'"'s body and causing the fluid to move from the reservoir into the means for delivering a fluid into a patient'"'"'s body upon receiving a command actuating same, and a safety valve assembly comprising a first substrate, a deflectable, moveable upper member having upper and lower surfaces, a compressible seal having upper and lower surfaces, a deflectable, moveable lower member having upper and lower surfaces, and means for controllably energizing and deflecting the lower member by providing an output signal thereto, wherein the upper surface of the upper member forms a portion of the fluid reservoir and is in contact with the fluid, the fluid exerting a pressure on the upper surface of the upper member, the lower surface of the upper member engaging the top surface of the seal, the lower surface of the seal being affixed to the lower member and seatable against the first substrate, the upper surface of the seal being seatable against the lower surface of the upper member, the lower surface of the upper member being mechanically biased against the upper surface of the seal when the seal is in a closed position, the energizing and deflecting means being electrically coupled to the upper and lower surfaces of the lower member, the lower member being deflectable or moveable between a first non-energized position in which movement of the fluid from the reservoir into the means for delivering the fluid into the patient'"'"'s body is blocked and the seal is in a closed position, and a second energized position in which the movement of the fluid from the reservoir into the means for delivering the fluid into the patient'"'"'s body is permitted as the seal is further pushed against the lower surface of the upper member into an open position through deflection or movement of the lower member occurring in response to the output signal being provided to the lower member, the fluid moving into the means for delivering the fluid into the patient'"'"'s body and the upper member being deflected further inwardly into the fluid reservoir when the seal is pushed into the open position, the method comprising:

(a) providing the hermetically sealed enclosure;

(b) providing the fluid reservoir;

(c) providing the means for delivering the fluid into the patient'"'"'s body;

(d) providing the pump;

(e) providing the safety valve assembly, and

(f) operatively connecting the hermetically sealed enclosure, the fluid reservoir, the means for delivering the fluid into the patient'"'"'s body, the pump and the safety valve assembly to one another.

56. A method of infusing a beneficial agent or drug into a patient with an implantable beneficial agent infusion device, the device comprising an hermetic enclosure, a fluid reservoir positioned at least partially within the hermetic enclosure, the fluid reservoir having means for maintaining a fluid containing a beneficial agent disposed therewithin between a first pressure and a second pressure, means for delivering the fluid into a patient'"'"'s body, a controllable pump, the pump communicating with the reservoir and the means for delivering the fluid into a patient'"'"'s body and causing the fluid to move from the reservoir into the means for delivering a fluid into a patient'"'"'s body upon receiving a command actuating same, and a safety valve assembly comprising a first substrate, a deflectable, moveable upper member having upper and lower surfaces, a compressible seal having upper and lower surfaces, a deflectable, moveable lower member having upper and lower surfaces, and means for controllably energizing and deflecting the lower member by providing an output signal thereto, wherein the upper surface of the upper member forms a portion of the fluid reservoir and is in contact with the fluid, the fluid exerting a pressure on the upper surface of the upper member, the lower surface of the upper member engaging the top surface of the seal, the lower surface of the seal being affixed to the lower member and seatable against the first substrate, the upper surface of the seal being seatable against the lower surface of the upper member, the lower surface of the upper member being mechanically biased against the upper surface of the seal when the seal is in a closed position, the energizing and deflecting means being electrically coupled to the upper and lower surfaces of the lower member, the lower member being deflectable or moveable between a first non-energized position in which movement of the fluid from the reservoir into the means for delivering the fluid into the patient'"'"'s body is blocked and the seal is in a closed position, and a second energized position in which the movement of the fluid from the reservoir into the means for delivering the fluid into the patient'"'"'s body is permitted as the seal is further pushed against the lower surface of the upper member into an open position through deflection or movement of the lower member occurring in response to the output signal being provided to the lower member, the fluid moving into the means for delivering the fluid into the patient'"'"'s body and the upper member being deflected further inwardly into the fluid reservoir when the seal is pushed into the open position, the method comprising:

(a) energizing the lower member and causing same to move;

(b) moving the seal into the open position in response to the lower member being energized and moving, and

(c) causing at least a portion of the fluid contained in the reservoir to flow into the means for delivering the fluid into the patient'"'"'s body.